FDA 483 - FANCYSTAGE, UNIPESSOAL, LDA. - January 26, 2024

FANCYSTAGE, UNIPESSOAL, LDA., an OTC drug manufacturer in Trofa, Portugal, received a Form FDA 483 with seven observations during an inspection from January 22-26, 2024. The observations highlight significant deficiencies in production and process controls, equipment cleaning and validation, stability testing, OOS investigations, test method validation, quality control unit responsibilities, and labeling/packaging material procedures. These issues indicate a broad lack of established and followed written procedures essential for ensuring drug product quality and safety.